1. Technical Field
The present invention relates to registries of clinical trial participants. More specifically, the present invention relates to methods of preventing participants from enrolling in multiple clinical trials simultaneously, and to perform other types of checks on participants, across all types of drug and device trials in all phases of clinical research.
2. Background Art
There are many research studies conducted by various institutions and companies that make up “clinical trials”. These clinical trials are generally used to verify the safety and efficacy of pharmaceuticals, biopharmaceuticals, and medical devices for the FDA. There are many different types of clinical trials, including treatment trials, prevention trials, diagnostic trials, screening trials, and quality of life trials.
The general public can enroll in clinical trials if they meet the criteria of the particular trial, such as having or not having a certain medical condition, currently taking a particular type of medicine, or having certain health characteristics. Clinical trials can be beneficial to many people who have exhausted currently approved treatments for their conditions since they allow such people to seek experimental procedures in order to improve their quality of life. People enrolled in clinical trials must also be aware of their risks, such as side effects and adverse reactions, or the fact that the treatment might not provide any results. There is a lot of motivation for people, especially in bad economic times, to join clinical trials because they are compensated monetarily to receive medical evaluation and care as well as free medication. However, some people try to enroll in clinical trials more than once under false information, or in several clinical trials at the same time. This not only can be dangerous to the person's health, but it can result in unreliable data for the organization conducting the trial.
There are several methods currently used for maintaining registries for clinical trials. For example, U.S. Patent Application Publication No. 2008/0052125 to Bennett, et al. discloses a method for maintaining the contact information of an enrollee in a clinical study while maintaining the anonymity of the enrollee from the clinical study sponsor. The method includes: (1) obtaining contact information for the enrollee in the clinical study; (2) entering the contact information into a database; (3) using a contact cascade on a scheduled, periodic basis to contact the enrollee using the contact information from the database to ensure that the contact information is correct; and (4) updating the contact information if a contact is made with the enrollee and the contact information needs to be updated to be accurate. While this method keeps track of contact information, it cannot easily be used to prevent multiple enrollments under false information.
U.S. Patent Application Publication No. 2008/0033658 to Dalton, et al. discloses computers, computer program products, and methods for identifying a plurality of subjects for a clinical trial. A candidate set of molecular profiles in a stored plurality of molecular profiles are identified. Each such profile has measurements for a discriminating set of cellular constituents that match the measurements of corresponding cellular constituents in a responder set of biological samples, thereby identifying the plurality of subjects for the trial from those subjects from which the candidate set of molecular profiles were derived. Each respective molecular profile in the stored plurality of profiles has measurements of a plurality of cellular constituents from a respective biological sample in a plurality of samples obtained from a first plurality of subjects. The discriminating set of cellular constituents is identified from those cellular constituents in the plurality of cellular constituents whose measurement values discriminates between the responder and nonresponder sets of biological samples. This method is used to select specific candidates for a particular trial based on their biological samples, but is not used to prevent multiple enrollments.
U.S. Patent Application Publication No. 2010/0023870 to Baker discloses an apparatus and methods that implement a computer-based system and procedure for the efficient and effective operation of one or more clinical trials using an institutional review board (IRB). The various methods are deployed against the backdrop of an Internet-based Software As A Service (SaaS) platform, allowing access to the system by all relevant participants. Each authorized participant in the clinical trial can have a customized and customizable view of the clinical trial and interact with the other participants electronically. The various documents required for completion of the clinical trial or study, as well as the various compliance documents needed to satisfy regulatory agencies are all available for review via the Internet. By utilizing the methods and system of the present invention, greater protection is offered for the human subjects of the clinical trials. Further, the sponsors, investigators, and the study participants can experience increased productivity. Finally, FDA mandated information can be more readily tracked and, accordingly, compliance with FDA guidelines can be enhanced. This method is directed to controlling information pertaining to the trials, but does not prevent multiple enrollments.
U.S. Patent Application Publication Nos. 2005/0159654 and 2003/0130871 to Rao, et al. disclose a system and method for selecting prospective patients for a clinical trial. In various embodiments, a clinical trials brokerage is configured to receive requests from drug companies for lists of persons meeting specified criteria for clinical trials. Patient records are retrieved from a structured computerized patient record (CPR) data warehouse populated with comprehensive patient information mined from unstructured hospital records. A list of persons for whom consent was obtained can be outputted and forwarded to the entity interested in performing the clinical trial and which requested the list. Anonymity of a patient can be maintained until the patient provides consent to participate in the clinical trial. This method also does not provide any secure means of preventing multiple enrollments in trials.
U.S. Patent Application Publication No. 2004/0006553 to de Vries, et al. discloses a method of conducting clinical trials over a network (e.g. the Internet or telephone grid). All trial participants and all trial investigators are asked to provide a baseline biometric reading, consisting of one or more of voiceprint, fingerprint, iris scan, electronic signature or other biometric modality, along with one or more identifiers such as their name, a user name and password combination, etc. The provided biometric information and identifiers are then permanently recorded into the biometric consent database. This biometric consent database is then used to obtain informed consent verified with biometric authentication from the enrolled trial participants and investigators. A unique code can be assigned to each trial participant. This method does not provide any way to maintain the integrity of a trial and prevent multiple enrollments or protocol violations.
U.S. Patent Application Publication No. 2010/0185462 to Lungescu, et al. discloses ClinicalRSVP, a web-based subject registry used by investigators to make better-informed enrollment decisions for clinical research studies. Research sites can report dose dates of subjects for the purpose of identifying ineligible subjects and ensuring against dual enrollment. Fingerprint biometric identification (or other biometric information, such as iris, retinal, or facial recognition or DNA) can be used along with other identifying information such as initials, birth date, sex, and last four digits of a social security or tax ID number. The subject is fingerprinted when screened for the trial, the fingerprint is then scanned, and a code is generated and stored in a database along with the other identifiers. The registry is searchable for a subject's information. ClinicalRSVP is used for phase I trials. There are several disadvantages of using biometric fingerprint technology with this system. Firstly, the technology does not function accurately in a significant percentage of cases. Many senior subjects or laborers are especially prone to problems with this technology as the system has difficulty reading the fingerprints. To supply all research sites in the country is not only expensive, but remains impractical and problematic as well. There are hardware and software installations required with this technology, which adds cost and time. When problems are encountered with fingerprint scanning, it slows down the entire screening process. Many potential research subjects have concerns about leaving biometric information with the research site. Clinical RSVP remains focused on early phase studies as providing fingerprint scanners to every research site across the country would be too expensive and time consuming. Clinical RSVP therefore does not have penetration to later phase studies, and does not prevent other key protocol violations, and many subjects are known to cross between phase 1 studies and later phase studies.
While many of the above described systems can generate databases of prospective participants in clinical trials, there is no unified system to stop research subjects from enrolling in more than one clinical trial at a time across all phases of clinical research and all therapeutic areas in both device and/or drug clinical trials, or waiting the mandated waiting time or washout period between clinical trials, exclusionary criteria that are listed in most drug and device clinical trials. Therefore, there remains the need for an improved screening system for clinical trials to reduce costs of clinical research and improve clinical research safety and data quality.